The Food and Drug Administration (FDA) on Tuesday authorized the emergency use of a new combination of drugs with antibodies from Eli Lilly that, according to the company, can treat mild and moderate cases of the coronavirus.
The FDA authorization is for a treatment that uses bamlanivimab and etesevimab. It can be used to treat mild or moderate cases of COVID-19 in adult and pediatric patients who test positive for the virus and who are at high risk of progression to serious illnesses. The treatment cannot be used in hospitalized patients or who require coronavirus oxygen therapy.
The FDA had previously authorized a treatment for Eli Lilly that only used bamlanivimab.
The new authorization allows the federal government to distribute treatment to state and territorial health departments to give to certain units.
“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand the potential treatment options that healthcare professionals can use to fight this pandemic,” said Patrizia Cavazzoni, interim director of the FDA Drug Center for Evaluation and Research.
Emergency use authorization follows data showing that bamlanivimab and etesevimab administered together reduced the risk of hospitalizations and death from COVID-19 by 70 percent.
Eli Lilly praised the authorization, noting that it will add to the bamlanivimab that is already in circulation and says it has helped to reduce hospitalizations.
“Lilly has dedicated our time, resources and experience to discover and develop therapies to treat COVID-19,” said Daniel Skovronsky, scientific director at Eli Lilly. “Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.”
Eli Lilly manufactured 250,000 doses of the treatment during the first quarter of 2021 and plans to have made up to one million doses by mid-year.
The news arrives as cases decrease across the country, but remain at alarming levels. There are still more than 27 million cases and more than 468,000 people have died in the country from the virus. Concerns about the virus only increased as a number of variants – which appear more infectious than the original strain – spread across the globe.
“With the risk of resistance emerging as multiple strains of the virus emerge, bamlanivimab and etesevimab together can enable efficacy against a wider range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world ”Said Skovronsky.